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In June the U.S. FDA approved opens in a new tab or window colchicine (Lodoco) as the first anti-inflammatory drug for the prevention of heart attacks and strokes among people with established heart disease or multiple risk factors. One recent reviews opens in a new tab or window reported that inflammation is a better predictor of future cardiovascular events and death than elevated cholesterol. So, the availability of a medicine that addresses inflammation is good news. But the dark side to this approval is about money.
Colchicine is not a new drug. It has been used for centuries. In fact, there are reports it was used to treat gout in ancient Greece over 2,000 years ago and it has remained a mainstay in gout treatment opens in a new tab or window. For decades, it has also been used to treat familial Mediterranean fever and pericarditis. Over the last few years, a significant number of studies opens in a new tab or window have documented that colchicine reduces the risk of heart attacks and strokes among people with established heart disease. One large study opens in a new tab or window published in 2019 followed heart disease patients for nearly 2 years and tabulated how many people died from cardiovascular causes, were resuscitated, experienced cardiac arrest, had a heart attack or stroke, or needed urgent hospitalization. In comparison to those randomly assigned to take a placebo, those taking colchicine were 23% less likely to experience one of these outcomes.
Meanwhile, Agepha just released a retail price for Lodoco of $621 for a 30-day supply -- nearly $21/pill. It will be available with a coupon at Walgreens opens in a new tab or window for $170/month or about $5.66/pill. Using either the retail or coupon price, Lodoco can cost as much as four to six times more than Colcrys Opens in a new tab or window. Yet, Colcrys and Lodoco are essentially the same drug. Both have only one active ingredient -- colchicine. The only difference is a tiny variation in the dose. Colcrys has 0.6 mg of colchicine, while Lodoco has 0.5 mg -- a difference that could be considered of no clinical consequence. Doctors who want to use colchicine to prevent heart disease will be able to legally write off label prescriptions for the lower cost Colcrys. However, modern corporate medicine may deny payment because the dose of 0.6 mg was not approved for this indication (heart disease prevention). Insurers, regulators, or prescribers could theoretically argue that the higher dose was not tested for heart disease prevention and that 0.6 mg could be more toxic than 0.5 mg. Further, many physicians and healthcare provider groups avoid off label prescriptions because it may affect their quality ratings.
https://www.medpagetoday.com/opinion/second-opinions/106756
Colchicine is not a new drug. It has been used for centuries. In fact, there are reports it was used to treat gout in ancient Greece over 2,000 years ago and it has remained a mainstay in gout treatment opens in a new tab or window. For decades, it has also been used to treat familial Mediterranean fever and pericarditis. Over the last few years, a significant number of studies opens in a new tab or window have documented that colchicine reduces the risk of heart attacks and strokes among people with established heart disease. One large study opens in a new tab or window published in 2019 followed heart disease patients for nearly 2 years and tabulated how many people died from cardiovascular causes, were resuscitated, experienced cardiac arrest, had a heart attack or stroke, or needed urgent hospitalization. In comparison to those randomly assigned to take a placebo, those taking colchicine were 23% less likely to experience one of these outcomes.
Meanwhile, Agepha just released a retail price for Lodoco of $621 for a 30-day supply -- nearly $21/pill. It will be available with a coupon at Walgreens opens in a new tab or window for $170/month or about $5.66/pill. Using either the retail or coupon price, Lodoco can cost as much as four to six times more than Colcrys Opens in a new tab or window. Yet, Colcrys and Lodoco are essentially the same drug. Both have only one active ingredient -- colchicine. The only difference is a tiny variation in the dose. Colcrys has 0.6 mg of colchicine, while Lodoco has 0.5 mg -- a difference that could be considered of no clinical consequence. Doctors who want to use colchicine to prevent heart disease will be able to legally write off label prescriptions for the lower cost Colcrys. However, modern corporate medicine may deny payment because the dose of 0.6 mg was not approved for this indication (heart disease prevention). Insurers, regulators, or prescribers could theoretically argue that the higher dose was not tested for heart disease prevention and that 0.6 mg could be more toxic than 0.5 mg. Further, many physicians and healthcare provider groups avoid off label prescriptions because it may affect their quality ratings.
https://www.medpagetoday.com/opinion/second-opinions/106756
